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Complexity in Medical Products

Flu A/B ASR

Description:... characteristics are not established. ASRs can only be sold to clinical laboratories regulated under the CLIA of 1988, as qualified to perform high complexity testing under 42 CFR part 493 or under VHA directive 1106. ** See specific ASR product datasheet for internal control information. ...
Company:Cepheid

mecA ASR

Description:... characteristics are not established. ASRs can only be sold to clinical laboratories regulated under the CLIA of 1988, as qualified to perform high complexity testing under 42 CFR part 493 or under VHA directive 1106. ** See specific ASR product datasheet for internal control information. ...
Company:Cepheid

Mycoplasma pneumoniae ASR

Description:... characteristics are not established. ASRs can only be sold to clinical laboratories regulated under the CLIA of 1988, as qualified to perform high complexity testing under 42 CFR part 493 or under VHA directive 1106. ** See specific ASR product datasheet for internal control information. ...
Company:Cepheid

RSV ASR

Description:... characteristics are not established. ASRs can only be sold to clinical laboratories regulated under the CLIA of 1988, as qualified to perform high complexity testing under 42 CFR part 493 or under VHA directive 1106. ** See specific ASR product datasheet for internal control information. ...
Company:Cepheid

Staphylococcus aureus (SPA) ASR

Description:... characteristics are not established. ASRs can only be sold to clinical laboratories regulated under the CLIA of 1988, as qualified to perform high complexity testing under 42 CFR part 493 or under VHA directive 1106. ** See specific ASR product datasheet for internal control information. ...
Company:Cepheid

Tag-It Cystic Fibrosis ASPE Mix

Description:... The Tag-It™ Cystic Fibrosis ASR reagents can be used by high complexity CLIA approved laboratories for detection of up to 70 mutations and 6 variants (polymorphisms) in the cystic fibrosis transmembrane conductance ...
Company:Tm Bioscience Corporation

Tag-It Cystic Fibrosis ASPE Mix B

Description:... The Tag-It™ Cystic Fibrosis ASR reagents can be used by high complexity CLIA approved laboratories for detection of up to 70 mutations and 6 variants (polymorphisms) in the cystic fibrosis transmembrane conductance ...
Company:Tm Bioscience Corporation

Tag-It Cystic Fibrosis PCR Mix B

Description:... The Tag-It™ Cystic Fibrosis ASR reagents can be used by high complexity CLIA approved laboratories for detection of up to 70 mutations and 6 variants (polymorphisms) in the cystic fibrosis transmembrane conductance ...
Company:Tm Bioscience Corporation

Tag-It Cystic Fibrosis PCR Mix

Description:... The Tag-It™ Cystic Fibrosis ASR reagents can be used by high complexity CLIA approved laboratories for detection of up to 70 mutations and 6 variants (polymorphisms) in the cystic fibrosis transmembrane conductance ...
Company:Tm Bioscience Corporation

ResultNet/Plus Software

Description:... Dawnings ResultNet/Plus software allows you to concentrate on running your lab, not your communications network. ResultNet/Plus eliminates the complexity associated with transmitting result data from largescale or multi-site laboratories to host information systems, by providing a central location for ...
Company:Dawning Technologies, Inc.

A1cNow InView System

Description:... with immediate access to quantitative A1C status the "gold standard" indicator of diabetes management without the time, high cost and complexity of reference labs or instrument-based ....
Company:Metrika, Inc.

Legionella pneumophila IgG/IgM

Description:... pneumophila (Legionella) serogroups 1-6 in serum from patients with clinical suspicion of Legionella Disease. For in vitro diagnostic use. High complexity ....
Company:Trinity Biotech

Growth Hormone Binding Protein ELISA Test

Description:... (2). The biological role of the GHBP is still unclear due partly to the previous lack of reliable and convenient assays and also due to the complexity of the in vitro effects (3). The main clinical application of GHBP measurements is in the diagnosis of genetic growth hormone insensitivity (Laron ...
Company:Diagnostic Systems Laboratories, Inc.

Applied Biosystems 3730xl DNA Analyzer

Description:... The 96-capillary 3730xl DNA Analyzer reduces the time, cost, and complexity of large-scale projects. Higher optical sensitivity and advanced polymers enable you to obtain higher-quality sequencing data for less. ...
Company:Applied Biosystems

Captia™ Varicella-Zoster Virus IgM

Description:... antibody to Varicella-Zoster virus in human serum as an aid in the diagnosis of primary infection or reactivation. For in vitro diagnostic use. High complexity ....
Company:Trinity Biotech

Captia™ Varicella-Zoster Virus IgG (5)

Description:... or a significant rise in antibody level, as an aid in the diagnosis of primary infeciton or reactivation with VZV. For in vitro diagnostic use. High complexity ....
Company:Trinity Biotech

Captia™ Varicella-Zoster Virus IgG

Description:... or a significant rise in antibody level, as an aid in the diagnosis of primary infeciton or reactivation with VZV. For in vitro diagnostic use. High complexity ....
Company:Trinity Biotech

Captia™ Mumps IgM

Description:... in human serum to Mumps for the determination of immunological experience The performance characteristics of this kit have not been established. High complexity ....
Company:Trinity Biotech

Captia™ Mumps IgG (5)

Description:... seroconversion or a significant rise in antibody, as an aid in the diagnosis of a recent or current infection. For in vitro diagnostic use. High complexity ....
Company:Trinity Biotech

Captia™ Mumps IgG

Description:... seroconversion or a significant rise in antibody, as an aid in the diagnosis of a recent or current infection. For in vitro diagnostic use. High complexity ....
Company:Trinity Biotech

Captia Measles IgM (2 plate)

Description:... Immunosorbent Assay (ELISA) is intended for the in vitro determination of Measles IgM antibodies in human serum. For in vitro diagnostic use. High complexity ....
Company:Trinity Biotech

Captia Measles IgM

Description:... Immunosorbent Assay (ELISA) is intended for the in vitro determination of Measles IgM antibodies in human serum. For in vitro diagnostic use. High complexity ....
Company:Trinity Biotech

Captia Measles IgG (5)

Description:... seroconversion or a significant rise in antibody as an aid in the diagnosis of recent or current infection. For in vitro diagnostic use. High complexity ....
Company:Trinity Biotech

Captia Measles IgG

Description:... seroconversion or a significant rise in antibody as an aid in the diagnosis of recent or current infection. For in vitro diagnostic use. High complexity ....
Company:Trinity Biotech

S/5 Avance Carestation

Description:... and respiratory data on full-color displays. Consistent menus, quick key actions and alarm management minimize the need for training and reduce complexity during critical and non-critical events. The S/5 Avance Carestation is setting a standard for electronic anesthesia gas mixing systems by offering ...
Company:Datex-Ohmeda, Inc.

Parvovirus (Erythrovirus) B-19 ASR

Description:... characteristics are not established. ASRs can only be sold to clinical laboratories regulated under the CLIA of 1988, as qualified to perform high complexity testing under 42 CFR part 493 or under VHA directive 1106. ** See specific ASR product datasheet for internal control information. ...
Company:Cepheid

Enterovirus ASR

Description:... characteristics are not established. ASRs can only be sold to clinical laboratories regulated under the CLIA of 1988, as qualified to perform high complexity testing under 42 CFR part 493 or under VHA directive 1106. ** See specific ASR product datasheet for internal control information. ...
Company:Cepheid

HSV Typing ASR

Description:... characteristics are not established. ASRs can only be sold to clinical laboratories regulated under the CLIA of 1988, as qualified to perform high complexity testing under 42 CFR part 493 or under VHA directive 1106. ** See specific ASR product datasheet for internal control information. ...
Company:Cepheid

Bordetella pertussis ASR

Description:... characteristics are not established. ASRs can only be sold to clinical laboratories regulated under the CLIA of 1988, as qualified to perform high complexity testing under 42 CFR part 493 or under VHA directive 1106. ** See specific ASR product datasheet for internal control information. ...
Company:Cepheid

HSV Non-Typing ASR

Description:... characteristics are not established. ASRs can only be sold to clinical laboratories regulated under the CLIA of 1988, as qualified to perform high complexity testing under 42 CFR part 493 or under VHA directive 1106. ** See specific ASR product datasheet for internal control information. ...
Company:Cepheid

402 Dilutor-Dispenser, single-syringe, 110-220v

Description:... with the same reliability and performance as Gilsons other manual liquid handling products. It is ideal for routine laboratory workwhatever the complexity of your sample ....
Company:Gilson, Inc

402 Dilutor-Dispenser, single-syringe, 220v (French version)

Description:... with the same reliability and performance as Gilsons other manual liquid handling products. It is ideal for routine laboratory workwhatever the complexity of your sample ....
Company:Gilson, Inc

PL-A741 Mono 1.3 Megapixel Machine Vision Camera

Description:... simple to use package. With triggering and GPO capabilities on-board the camera and no need for a separate frame grabber in the computer, your system complexity and cost are reduced. Data from the camera is transferred to the computer over a standard, inexpensive FireWire adapter and cable, which supplies ...
Company:PixeLINK

True/Lok External Fixator

Description:... correction Simplified products True/Lok External Fixation components are designed to reduce the time involved with frame assembly and the complexity of intra-operative and post-operative frame adjustment. The fully modular, preassembled distractors and hinges eliminate the need to stock large ...
Company:Encore Medical Corporation

Minimally Invasive Hip Instruments

Description:... designed to facilitate THA through a mini-incision using a posterior-lateral incision. The comprehensive set of instruments helps reduce the complexity of a minimally invasive THA by optimizing exposure and access to the hip while protecting the delicate soft tissue ....
Company:Zimmer, Inc.

Hoffmann® II Compact™

Description:... the anatomy of the distal radius by allowing independent movement of its clamp in multiple planes. One of the main goals has been to reduce complexity of frame design, while providing total versatility and ease of use. The Hoffmann® II Compact™ system can be used with single or multi-pin ...
Company:Stryker Corporation

ACCUSTRIP Strep A (ll) Test-CLIA waived

Features:... Rapid Strep A antigen test. CLIA complexity : WAIVED Kit includes 25 test packs, 25 sterile throat swabs, extraction reagent, positive control, and negative ....
Company:JANT Pharmacal Corp.

ACCUTEST H. pylori Test (Whole Blood)

Features:... Rapid whole blood test for H. pylori. Test results in 5 minutes. CLIA complexity : waived. Cassette format. ...
Company:JANT Pharmacal Corp.

ACCUTEST Mononucleosis Whole Blood Test

Features:... Results in 5 minutes. CLIA complexity : waived. Cassette format. ...
Company:JANT Pharmacal Corp.
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